JP5373069B2 - Denture adhesive composition and method - Google Patents

Description

  The present invention relates to a denture adhesive composition, in particular an improved denture bonding method, and a composition comprising an adhesive component and a clay index improver.

  Conventional removable dentures, denture bases, partial dentures, etc. include teeth attached to a suitable plate or pedestal. Dentures are originally tailored to individual users, but their suitability changes over time and can lead to slippage or discomfort. Some users prefer the special prevention of slipping and misalignment regarding the quality of dentures. Denture adhesives are used to temporarily bond dentures to the oral surface, in particular to the oral mucosa, giving the wearer a special sense of security. Denture adhesives are usually applied to dentures, oral surfaces, or both at the beginning of the day when dentures are installed in the mouth.

  Unfortunately, denture adhesives tend to bioerode during the day due to saliva action, chewing, drink intake, and the like. This corrosion causes loss of adhesiveness, leaching of the adhesive into the oral cavity, displacement and the like. Thus, there is a need for improved denture adhesives.

  According to one embodiment, the present invention is selected from the group consisting of a) denture adhesive components, and b) polymethacrylates, olefin copolymers, hydrogenated styrene-diene copolymers, styrene polyesters, and combinations thereof. The present invention relates to a denture adhesive composition containing a viscosity index improver.

  These and other embodiments of the present invention will be more fully understood in view of the following detailed description.

  A detailed description of the present invention is given below.

Definition of Terms As used herein, the abbreviation “cm” means centimeter. As used herein, the abbreviation “mm” means millimeter. As used herein, the abbreviation “g” means gram. As used herein, the abbreviation “P” means “Pascal”. As used herein, the abbreviation “s” means “seconds”. As used herein, the abbreviation “Ps” means “Pascal-seconds”. As used herein, the abbreviation “oz” means “ounces (1 ounce = 29.6 mL)”.

  As used herein, the term “denture” means an upper or lower denture, a partial upper or lower denture, or a combination of partial and complete dentures.

  As used herein, the term “viscosity index improver” means a water-insoluble material that further stabilizes the viscosity and / or rheology of the incorporated material as the temperature rises above a specified range. To do. For denture adhesive products, the specified range is between about 25 ° C and about 60 ° C.

  As used herein, the term “dispensable / dispensable from tube” means a composition that can be dispensed from a small denture adhesive tube under manual pressure. The small denture adhesive tube is made of a foil laminate, is about 8.8 cm (3.5 inches) long, about 1.21 cm (0.48 inches) wide, and about 7.3 mL (0.25). Ounce) product. The inner diameter of the nozzle of this mini denture adhesive tube is approximately 0.48 cm (0.19 inch) and the nozzle length is approximately 0.96 cm (0.38 inch). An example of a small denture adhesive tube is a tube with a sample size of 7.3 mL (0.25 ounce) and is supplied by Alcan under stock number 2293.

  As used herein, the term “preformed” refers to a denture adhesive composition formed into a sheet that is suitably shaped to conform to the denture.

  As used herein, the terms “olefin polymer”, “hydrogenated styrene-diene polymer”, “styrene polyester”, and “polymethacrylate” exclude elastomers and rubbers.

  As used herein, a “safe and effective amount” means within the scope of sound medical / dental judgment that the condition to be treated is significantly (goodly) altered or the benefit sought is good. Means an amount of drug that is large enough to modify, but small enough to avoid serious side effects (at a reasonable benefit / risk ratio). The safe and effective amount of the drug depends on the particular condition being treated, the age and physical condition of the patient being treated, the severity of the condition, the duration of the treatment, the nature of the combination therapy, the particular form of the substance used, and the agent May vary depending on the particular solvent to which is applied.

  As used herein, the term “AVE / MA” refers to an alkyl vinyl ether-maleic acid or maleic anhydride copolymer. As used herein, the term “mixed salts” refers to AVE / MA, etc., in which at least two different cations are mixed together on the same polymer or mixed with other salts. Means a salt of a polymer.

  As used herein, the term “toxicologically acceptable” is used to describe a substance whose toxic properties are suitable for administration to humans and / or animals.

  As used herein, the term “non-aqueous” means a composition that is substantially free of added water. “Substantially free” means that no free water has been added to the composition, but the composition may contain no more than 5% water as part of the other ingredients. .

  As used herein, the term “water-insoluble” means a substance that does not dissolve when exposed to water, but may disperse to different degrees. In general, a material is water insoluble if less than about 10% dissolves in water.

  As used herein, the term “bioerodible” refers to the fact that a composition will corrode over time by physical and / or chemical effects when exposed to excess water or saliva. means. The composition may erode completely or almost completely, but eventually the composition loses its original form and / or integrity. For example, after application and use for at least about 24 hours in the oral cavity, the composition does not have sufficient product integrity to easily separate or peel in its original form from the denture or oral cavity surface.

  Unless otherwise stated, the term “melting point” as used herein is sufficient fluid to droop from a thermometer used in determining substances under the given conditions listed in ASTM D-127. It means the drop melting point, which is the temperature at which it becomes. If ASTM D-127 is inadequate for the substance of interest, ASTM D-3954 can be used instead.

  Unless otherwise stated, the term “derivative” as used herein means when the polymer backbone is unchanged but the side groups / chains and / or end groups are altered.

  As used herein, the term “silicone” means a siloxane polymer based on a structure having alternating silicon and oxygen atoms with various organic groups attached to silicon.

  As used herein, the term “about” means plus or minus 10%.

  All other percentages used herein are by weight of the composition unless otherwise indicated.

  All measurements referred to herein are made at 25 ° C. unless otherwise specified.

Denture Adhesive Compositions and Methods Denture adhesive compositions have become products that are used daily by many people who seek better fit and / or more stability when wearing dentures. This has led to consumer demand for products with improved properties, such as long-lasting retention. The denture adhesive composition improves on such desired properties.

  Generally, the denture adhesive composition of the present invention includes an adhesive component and a viscosity index improver. Historically, viscosity index improvers have been a related term in the lubricant industry. The viscosity of the lubricant is closely related to its ability to reduce friction. The most desirable lubricant is one that easily moves the two surfaces while keeping the two moving surfaces separated to minimize friction. However, since the viscosity of the liquid tends to decrease with increasing temperature, many lubricants that function at relatively low temperatures are not viscous to function at relatively high temperatures, but are sufficiently viscous at relatively high temperatures. Tends to be too viscous at relatively low temperatures.

  For example, the automotive industry demands lubricants that can function over a wide range of conditions, such as those found in engines. Automotive lubricants must reduce friction between engine parts when starting from low temperatures (compared to engine operating temperatures) as well as during operation (up to 200 ° C.). The best oil (ie, lubricant) does not change much in viscosity in such a temperature range and therefore works well in that range.

  In order to better predict the temperature range over which the lubricant will function, the American Automobile Engineering Association (SAE) has established a viscosity index. The viscosity index emphasizes how the viscosity of the lubricant changes with temperature. The viscosity index indicates the viscosity of the material at any “low” temperature of 40 ° C. (100 ° F.) and at any “high” temperature of 100 ° C. (210 ° F.).

  After understanding the characteristics of a lubricant over a set temperature range, it was discovered that certain lubricants made their lubricant viscosity more consistent over a wider temperature range. For this reason, there is little decrease in the lubricant viscosity at relatively high temperatures. Having a high viscosity at high temperatures allows the lubricant to function better at high temperatures. A substance added to increase the viscosity at high temperature was defined as a viscosity index improver.

  Surprisingly, it has been found that the application of this principle is also related to denture adhesives. Generally, denture adhesive compositions include a denture adhesive component (eg, a salt of AVE / MA) dispersed in a water-insoluble component (eg, petrolatum). During use, water in saliva penetrates into the water-insoluble component and hydrates the denture adhesive component. Thus, the denture adhesive component is sticky to the mucosal tissue and the denture surface. The amount of hydration is affected by the amount of denture adhesive component, the amount of water-insoluble vehicle, and the viscosity of the water-insoluble vehicle, all three contributing to the overall viscosity of the denture adhesive composition. . The viscosity of the denture adhesive composition contributes to the speed and / or hydration amount of the denture adhesive component. Over time, excessive saliva and / or excessive hydration with fluid will cause the adhesive to be lost, thereby weakening the adhesion. As such, denture adhesive compositions having a high viscosity at the mouth temperature will be more resistant to hydration, at least in part due to the water-insoluble vehicle. Briefly, the temperature-resistance of the viscosity imparted by the viscosity index improver provides resistance to excessive hydration and thus retains more adhesive over time, making it a more durable improvement of denture adhesives Leads to function.

  Thus, the use of only a viscosity index improver or in combination with a water-insoluble component will improve the hydration properties of the denture adhesive and thereby provide improved retention. The temperature range most relevant to denture adhesives deals with the viscosity of denture adhesive compositions in the mouth from room temperature (25 ° C.) handling the viscosity of denture adhesives in dispensing containers (eg tubes or packaging containers) 40 It is in the range of ° C. When drinking a hot drink, the temperature in the mouth can reach 60 ° C. or higher, and the behavior of the composition at 40 ° C. is a good predictor of whether it has increased beneficial properties at 60 ° C. It is easy to become. Thus, denture adhesive-related viscosity index improvers make the viscosity more stable over the functional temperature range (ie, 25 ° C. to 60 ° C.).

  In view of the above, in one embodiment, the denture adhesive composition includes a uniform mixture of denture adhesive components and viscosity index improvers. In another embodiment, the denture adhesive composition comprises a homogeneous mixture of adhesive components dispersed in a viscosity index improver.

Denture Adhesive Component The present invention comprises a denture adhesive component in a safe and effective amount, usually from about 5% to about 99% by weight of the composition. In another embodiment, the denture adhesive component is about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40% to about 50%, 55%, 60%, 65% , 70%, 75%, or various combinations thereof. In another embodiment, the composition of the present invention comprises at least about 20% or at least about 30% by weight of the composition of a denture adhesive component. In certain specific embodiments, the denture adhesive component is present in an amount from about 10.0% to about 60.0%.

  In general, denture adhesive components are hydrophilic particles or hydrophilic liquids that become viscous when activated with moisture. For those activated by moisture, the moisture may be present in the denture adhesive composition itself as well as in the user's mouth, for example. In various embodiments, the denture adhesive component of the present invention is mucoadhesive, hydrophilic, water-soluble, has the property of swelling when exposed to moisture, and when combined with moisture, These various formulations are formed. In a further embodiment, the denture adhesive component is glycerin, polyoxamer, sorbitol, polyox, carbomer, polyacrylamides, polypeptides, natural gums, synthetic polymeric gums, AVE / MA, AVE / MA / IB, copolymer of maleic acid or anhydride and ethylene, styrene, and / or isobutylene, polyacrylic acid and / or polyacrylate thereof, polyitaconic acid, mucoadhesive polymer, water-soluble hydrocolloid, sugar, cellulose, It is selected from the group consisting of these derivatives and combinations thereof. Examples of such substances are Karaya gum, guar gum, gelatin, algin, sodium alginate, tragacanth, chitosan, acrylamide polymer, carboxypolymethylene, polyvinyl alcohol, polyamine, polyquaternary compound, polyvinylpyrrolidone, polyvinylpyrrolidone copolymer, cation Polyacrylamide polymers, AVE / MA salts and mixed salts, AVE / MA / IB salts and mixed salts, AVE / MA / styrene salts and mixed salts, AVE / MA / ethylene salts and mixed salts, polymeric acids , Polymer salts, and copolymers thereof, polyitaconate salts, polyhydroxy compounds, derivatives thereof, and combinations thereof.

  In one embodiment, the denture adhesive component comprises AVE / MA salts, AVE / MA mixed salts, cellulose derivatives (eg, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, corn starch, And combinations thereof), polyethylene glycol, Karaya gum, sodium alginate, chitosan, and combinations thereof. In yet another embodiment, the adhesive component is selected from the group consisting of AVE / MA mixed salts, cellulose derivatives, and combinations thereof.

  In another embodiment, the denture adhesive component comprises cellulose, cellulose derivatives, starch, starch derivatives, sugars, sugar derivatives, polyethylene oxides, polyethylene glycols, polyvinyl alcohols, carrageenan, alginates, karaya gums, xanthan gums, Guar gums, gelatins, algins, tragacanth, chitosan, acrylamide polymers, carboxypolymethylenes, polyamines, polyquaternary compounds, polyvinylpyrrolidone, alkyl vinyl ether / maleic anhydride polymers, alkyl vinyl ether / maleic anhydride polymers Selected from the group consisting of: salts of alkyls, mixed salts of alkyl vinyl ether / maleic anhydride polymers, polymeric acids, polymeric salts, polyhydroxy compounds, and combinations thereof

  In one embodiment, the adhesive component is a polymer salt of AVE / MA. In another embodiment, the adhesive component is a mixed salt of AVE / MA polymer. In a further embodiment, the AVE / MA copolymer comprises a group IA and 2A cation of the periodic table, yttrium, titanium, zirconium, vanadium, chromium, manganese, iron, nickel, copper, zinc, boron, aluminum And having a cation salt functionality comprising a cation selected from the group consisting of combinations thereof. In another embodiment, the adhesive component is selected from the group consisting of strontium, zinc, iron, boron, aluminum, vanadium, chromium, manganese, nickel, copper, yttrium, titanium, magnesium, calcium, sodium, and combinations thereof A mixed salt of an AVE / MA copolymer having a cationic salt function. In yet another embodiment, the cation is selected from the group consisting of strontium, zinc, iron, magnesium, calcium, sodium, and combinations thereof. In one embodiment, the adhesive component is a mixed salt of calcium and zinc of the AVE / MA copolymer. In another embodiment, the denture adhesive component comprises AVE / MA, a salt of AVE / MA, a mixed salt of AVE / MA, sodium carboxymethylcellulose, or a combination thereof. In one embodiment, the denture adhesive component comprises a combination of a mixed salt of AVE / MA and carboxymethylcellulose.

  In a further embodiment, the denture adhesive composition includes an additional adhesive component. In one embodiment, the additional adhesive component is present from the same concentration and is selected from those listed as adhesive components. In one embodiment, the additional adhesive component includes a cellulose derivative. In a further embodiment, the cellulose derivative comprises sodium carboxymethyl cellulose. In embodiments, the additional adhesive component is present in a range from about 5, 10, 15, 20% to about 30, 35, 40, 45, 50, 60%, or combinations thereof.

Water-insoluble components In some embodiments, the composition comprises a safe and effective amount of water-insoluble components. In one embodiment, this component ranges from about 1, 2, 5, 10, 20, 25, 30, 35% to about 45, 50, 60, 70, 90% by weight of the composition, or a combination thereof. Exists. In further embodiments, the water-insoluble component is present in an amount from about 20% to about 70%, from about 25% to about 60%, from about 35% to about 60% by weight of the composition. . In yet another embodiment, the water-insoluble component is substantially non-swelled in water. In another embodiment, the water-insoluble component is substantially non-swellable in water. In some embodiments, the non-swellable, water-insoluble component swells less than about 10%, 5%, 2%, or 1% in water.

  In one embodiment, the water-insoluble component comprises natural wax, synthetic wax, petrolatum, polyvinyl acetate, natural oils, synthetic oils, fats, silicone, silicone derivatives, dimethicone, silicone resin, essential oil, caprylic acid / It is selected from the group consisting of capric acid triglycerides, polybutene, oleic acid, stearic acid, and combinations thereof. In a further embodiment, the water-insoluble component comprises petrolatum, polyvinyl acetate, natural oils, synthetic oils, fats, silicone, silicone derivatives, dimethicone, silicone resin, polybutene, oleic acid, stearic acid, essential oil. , Caprylic / capric triglycerides, microcrystalline wax, or combinations thereof. In further embodiments, the water-insoluble component is substantially free of petrolatum. Examples of natural oils include, but are not limited to, vegetable oils (eg, corn oil), soybean oil, cottonseed oil, palm oil, coconut oil, mineral oil, animal oil (eg, fish oil), and the like. Examples of synthetic oils include, but are not limited to, silicone oils. In one embodiment, the water insoluble component comprises a natural oil. In a further embodiment, the natural oil comprises mineral oil. In one embodiment, the mineral oil is present in the composition from about 30% to about 50%, and in another embodiment from about 35% to about 45%.

  In some embodiments, the water insoluble component is a wax. Waxes are generally hydrocarbons (linear or branched alkanes and alkenes) ketones, diketones, primary and secondary alcohols, aldehydes, sterol esters, alkanoic acids, terpenes, (squalene) and mono It is made of various substances such as esters (wax esters). Different types of waxes include animal and insect waxes (beeswax, ibuta wax, shellac wax, whale wax, lanolin), plant waxes (bayberry wax, candelilla wax, carnauba wax, castor wax, esparto wax, Japan Waxes, jojoba oil, auricule wax, rice bran wax), mineral waxes (ceresin waxes, montan wax, ozokerite, peat waxes), petroleum waxes (paraffin wax), and synthetic waxes (polyethylene waxes, Fischer-Tropsch) Waxes, chemically modified waxes, substituted amide waxes, polymerized α-olefins).

  In one embodiment, the water-insoluble component is a natural or synthetic wax. In further embodiments, the natural wax is selected from the group consisting of animal waxes, vegetable waxes, mineral waxes, microcrystalline waxes, and combinations thereof. In another embodiment, animal waxes include beeswax, lanolin, shellac wax, lobster wax, and combinations thereof. In another embodiment, plant waxes include carnauba, candelilla, bayberry, sugarcane, and combinations thereof, and mineral waxes include fossil or ground wax (ozokerite, ceresin, montan), and petroleum waxes such as paraffin, As well as combinations thereof. In one embodiment, the waxes herein are natural waxes selected from the group consisting of beeswax, candelilla, candela, carnauba, paraffin, and combinations thereof. In various embodiments, the wax ranges from about 1, 2, 5, 8, 10, 15, 20, 40% to about 10, 20, 30, 40, 50, 60, 80%, or a combination thereof. Exists.

  In another embodiment, the natural wax is selected from the group consisting of paraffin wax, beeswax, candelilla wax, carnauba wax, and combinations thereof. Synthetic grade beeswax, candelilla, and carnauba waxes are also available that have properties similar to natural grades.

Viscosity Index Enhancer As noted above, the viscosity index improver stabilizes the viscosity of the denture adhesive composition over a range of operating temperatures (ie, about 25 ° C. to about 60 ° C.). Yet another mechanism is believed to contribute to the improved properties of denture adhesive compositions containing viscosity index improvers. Without being limited by theory, it is believed that at least some improved properties occur when at least some of the particles of the adhesive component are at least partially coated or surrounded by the viscosity index improver. Indeed, it has surprisingly been found that in at least some embodiments of the present invention, the viscosity index improver at least partially coats the particles of the adhesive component. This is especially seen when the denture adhesive composition is produced by heating to a viscosity index improver liquefaction temperature or higher and then cooling to room temperature. In some embodiments, the viscosity index improver can coat the adhesive component particles by solidifying or crystallizing within the pores and / or gaps of the adhesive component particles.

  In some embodiments, the adhesive component being coated / surrounded by the viscosity index improver can be washed away by, for example, incomplete hydration, excessive hydration (by saliva or drink), changes in mouth temperature ( It acts as a physical barrier that protects the adhesive particles from, for example, the ingestion of hot drinks such as coffee) and / or chewing. This can also be a better use and optimization of the adhesive component, which makes the function better. Improvements in functionality can lead to the ability to work with a small amount of product in order to obtain a retention that is equal to or better than the predecessor.

  Apart from understanding the general principles regarding viscosity index improvers, another way to determine whether a substance acts as a viscosity index improver in a denture adhesive composition is to look at the instantaneous viscosity ratio. This instantaneous viscosity ratio measures the viscosity ratio of a prototype sample at room temperature (25 ° C.) and high temperature (40 ° C.). The composition tends to have a higher viscosity at higher temperatures than the same composition without the viscosity index improver. This is important because denture adhesive compositions are generally used in the user's mouth (with dentures) above room temperature. Furthermore, the user's mouth temperature rises when a hot drink is ingested. The ability to maintain high viscosity at high temperatures contributes to better retention of denture adhesive compositions during use and less loss.

  The instantaneous viscosity ratio can be measured as outlined below. In one embodiment, the instantaneous viscosity ratio is greater than 0.25. In another embodiment, the instantaneous viscosity ratio is from about 0.25 to about 1.0. In further embodiments, the instantaneous viscosity ratio is about 0.25, 0.3, 0.4, 0.6, 0.7 to about 0.3, 0.4, 0.5, 0.8, 1 0.0 or a combination of these ranges. In further embodiments, the instantaneous viscosity ratio is from about 0.3 to about 0.8. In other embodiments, the instantaneous viscosity ratio is from about 0.3 to about 0.6, or from about 0.3 to about 0.5.

Some examples of viscosity index improvers include polymethacrylates, olefin copolymers, hydrogenated styrene-diene copolymers, styrene polyesters, or combinations thereof. In one embodiment, the viscosity index improver is poly (n-butyl vinyl ether), styrene-maleic anhydride copolymer, alkyl fumarate-vinyl acetate copolymer, alkylated polystyrene, poly (t-butyl styrene), and Selected from the group consisting of these combinations. Examples of polymethacrylates include, for example, acrylate-methacrylate copolymers, methacrylate-styrene copolymers, or combinations thereof. Other examples of viscosity index improvers are described in “Chemistry and Technology of Lubricants (2 ^nd Ed. 1997)” by Chapman and Hall. In one embodiment, the viscosity index improver comprises an olefin copolymer, a hydrogenated styrene-diene copolymer, or a combination thereof. All of the above viscosity index improvers are believed to provide the desired viscosity / rheological properties as described above.

  In some embodiments, the viscosity index improver is used in an amount of about 0.001% to about 90.0%. In various embodiments, the viscosity index improver is from about 1, 2, 5, 10, 15, 20, 30, 40% to about 10, 15, 20, 30, 40, 50, 60, 70, 80, or It exists in the range which combined 90% or these. In one embodiment, when the oral care composition is preformed, the viscosity index improver is present from about 40% to about 60%. In one embodiment, the viscosity index improver is present from about 1.0% to about 15.0% when the oral care composition can be dispensed from a tube.

Various Additives Plasticizers The compositions of the present invention may also optionally include one or more safe and effective amounts of toxicologically acceptable plasticizers. In various embodiments, the plasticizer concentration is from about 0.01% to about 40%, from about 1% to about 10%, or from about 2% to about 5% by weight of the composition. In another embodiment, the plasticizer is water insoluble.

  Suitable plasticizers of the present invention include polyols (such as sorbitol), glycerin, propylene glycol, acetylated monoglycerides, hydrolyzed starch hydrolysates, corn syrup, xylitol, glycerol monoesters of fatty acids, triacetin, diacetin, monoacetin, phthalates Dimethyl acid, diethyl phthalate, dioctyl phthalate, diethylene glycol, triethylene glycol, tricresyl phosphate, dimethyl sebacate, ethyl glycolate, ethyl phthalyl ethyl glycolate, o- and p-toluene ethyl sulfonamide, phthalic acid, glycerol triacetate , Citric acid, phosphoric acid, glycol, pentaerythritol ester of fatty acid, stearic acid, glycerol monostearate, polyethylene glycol, butyl Taryl butyl glycolate, dimethyl phthalate, dibutyl phthalate, triacetin, bird ethyl citrate, triethyl acetyl citrate, tributyl acetyl citrate, triphenyl phosphate, diethylene glycol, caprylic acid triglyceride, capric acid triglyceride, dicaprylic acid / capric acid Examples include, but are not limited to, propylene glycol, derivatives thereof, or combinations thereof.

Gelling Agents The compositions of the present invention may also optionally include one or more safe and effective amounts of toxicologically acceptable gelling agents. In various embodiments, the gelling agent comprises in the range of about 0.01% to about 40%, about 1% to about 10%, or about 2% to about 5% by weight of the composition. It is.

  As a suitable gelling agent of the present invention, a polyvinylpyrrolidone / eicosene copolymer sold under the trade name Ganex (registered trademark) V-220F by ISP, and a trade name Ganex (registered trademark) WP-660 from ISP. Tricontanyl polyvinylpyrrolidone sold and polyamide gelling agents such as Sylvaclear (R), Sylvacote (R), Sylvagel (R), and Uniclear (R) commercially available from Arizona Chemical, or Although what put these together is mentioned, it is not limited to these.

Therapeutically Active Substances Such denture adhesive compositions may include one or more therapeutically active ingredients. The therapeutically active agent can be present in a range from about 1, 5, 10, 15, 20, 25, 30% to about 3, 5, 10, 20, 30, 50, 70%, or combinations thereof. Examples of therapeutic active substances include antibacterial agents such as iodine, triclosan, peroxides, sulfonamides, bisbiguanides, or phenolic compounds, tetracycline, neomycin, kanamycin, metronidazole, cetylpyridinium chloride, domifene bromide, or Antibiotics such as lindamycin, anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone, potassium nitrate, strontium chloride, sodium fluoride, etc. Dental desensitizer, fluoride such as sodium fluoride, stannous fluoride, MFP (monofluorophosphate), anesthetic such as lidocaine or benzocaine, bleach such as peroxide, Candida albica Antifungal agents such as those for treating scan, insulin, steroids, therapeutic agents derived from herbs and other plants, as well as sodium bicarbonate. For other suitable therapeutically active substances, see Physicians Desk Reference 62 ^nd Ed. 2008 and the Physicians Desk Reference for non-presecription drugs, andherbs, 29 th Ed. It is stated in.

  According to one embodiment, the active substance is an anticalculus agent, a fluoride ion source, a tin ion source, a bleaching agent, an antibacterial agent, an anti-plaque agent, an antifouling agent, an anti-fouling agent, a gingivitis inhibitor, a calculus inhibitor, a tooth Peritonitis inhibitor, hypersensitivity agent, caries inhibitor, anti-inflammatory agent, nutrient, antioxidant, antiviral agent, antifungal agent, analgesic agent, anesthetic agent, H-2 antagonist, and combinations thereof Selected from the group.

Flavor, Aroma, and Sensory Active Substances The compositions of the present invention may comprise one or more ingredients that provide a flavor, aroma, and / or sensory effect (eg, warming or cooling agents). Suitable ingredients include, for example, menthol, winter green oil, peppermint oil, spearmint oil, leaf alcohol, clove bud oil, anethole, methyl salicylate, eucalyptol, cassia, 1-8 menthyl acetate, sage, eugenol, parsley oil Oxanone, α-irisone, marjoram, lemon, orange, propenyl guetol, cinnamon, vanillin, thymol, linalool, cinnamaldehyde glycerol acetal, derivatives thereof, and combinations thereof. In one embodiment, the active substance is a perfume such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde, or combinations thereof.

  These agents are about 0% to about 40% by weight of the composition, in another embodiment about 0.05% to about 5%, and in another embodiment about 0.1% to about It may be present at a concentration of 2% by weight.

Other various additives Other suitable ingredients include colorants, preservatives (eg, methyl and propylparabens), and rheology modifiers (eg, silicon dioxide). Rheology modifiers modify rheological properties such as viscosity, elasticity, and / or yield stress. Such colorants, preservatives, and rheology modifiers are about 0% to about 20% by weight of the composition, in another embodiment about 0.1%, 0.2, 1, 2, 5 to about 1, 5, 10, 20% by weight, or a combination of these.

  Further, the composition may include one or more solvents. These selective solvents can be miscible with and / or dissipated in-situ with viscosity index improvers, water-insoluble components, or both. In one embodiment, these solvents may be eliminated in situ by evaporation, dissolution, dispersion, bioabsorption, or any other suitable means. In one embodiment, the solvent includes silicones, hydrocarbons, isododecane, isohexadecane, isoeicosane, polyisobutene, or combinations thereof.

Denture Adhesive Composition Denture adhesive compositions can take many different forms, from liquid to solid. For example, the composition may be an emulsion, dispersion, slurry, gel, cream, paste, preform, and combinations thereof. In one embodiment, the denture adhesive composition is in the form of a gel, cream, or paste. In another embodiment, the denture adhesive composition can be extruded directly from a nozzle of a container such as a tube, syringe, and / or pump onto the denture surface or oral surface.

  In another embodiment, the denture adhesive composition is preformed. In one embodiment, the preformed composition fits in the gap between the gum and denture without substantial deformation. In a further embodiment, the preformed denture adhesive composition includes a backing layer.

Backing Layer Although the denture adhesive composition may be provided as a single film, it may be applied to the backing layer by painting, coating, or other methods. This backing layer can be provided as a single layer or a laminate formed from multiple layers such as foam, mesh, and / or other suitable materials. This backing layer may be water permeable, non-water permeable, partially water permeable, water soluble, water insoluble, corrosive, or a combination thereof. Furthermore, the backing layer may be continuous or discontinuous (eg, formed of a plurality of separate segments).

  In one embodiment, the backing serves as a protective barrier that protects the adhesive and / or active agent. The protective wall prevents the adhesive and / or active substance from leaching and / or eroding, for example, substantially by the wearer's lips, tongue, cheeks and saliva. Thereby, the denture adhesive composition can adhere to the oral cavity surface and / or denture over a longer period of time.

  The backing may include polymers, natural and synthetic fabrics, non-woven materials, foils, paper, rubber, and combinations thereof. The backing may be a single layer of material or a laminate comprising one or more layers. Preferably, the material is a variety of polymers or combinations of polymers that have bending stiffness and are compatible with denture adhesive compositions. Suitable polymers include polyethylene, ethyl vinyl acetate, polyester, ethyl vinyl alcohol, and combinations thereof. The backing is generally about 1 mm thick, preferably about 0.05 mm thick, more preferably about 0.001 to about 0.03 mm thick. The polyethylene backing is preferably less than about 0.1 mm, more preferably about 0.005 to about 0.02 mm thick.

  The shape of the backing can be any shape and size that covers the desired oral surface. In one embodiment, the backing has rounded corners. A rounded corner is defined as having no sharp corners or sharp edges. In one embodiment, the backing has a length of about 2 cm to about 12 cm, preferably about 4 cm to about 9 cm. The width of the backing depends on the area of the oral surface that it covers. In one example, the backing has a width of about 0.5 cm to about 4 cm, preferably about 1 cm to about 2 cm.

  The backing may include shallow pockets. When the denture adhesive composition is coated with the backing, the additional denture adhesive composition fills the shallow pocket and provides a reservoir for additional oral care substances. Furthermore, these shallow pockets help to texture the delivery system. The film preferably has shallow pockets arranged side by side. In general, a shallow pocket is approximately 0.4 mm wide and 0.1 mm deep. When these shallow pockets are provided in the backing and the denture care composition is applied in various thicknesses, the overall thickness of the delivery system is generally less than about 1 mm. Preferably, the overall width is less than about 0.5 mm.

  The backing is held in place on the oral cavity and / or denture surface by the adhesive attachment provided by the denture adhesive composition. Due to the viscosity and general tackiness of the denture adhesive composition, the backing can be applied to the oral cavity and / or denture surface during lips, teeth, tongue, and other things such as talking, drinking, etc. Adhering with adhesive without substantial slippage from frictional forces caused by the oral surface. In one embodiment, adhesion to the oral cavity and / or denture surface can be achieved by removing the backing by the wearer using fingers, fingernails, or rubbing with a cotton ball, swab or gauze pad. Is weak enough to remove the backing easily. Furthermore, in one embodiment, the delivery system can be easily removed from the surface without applying instruments, chemicals or drugs, or excessive friction. Examples of the chemical solvent include organic solvents known for use in the oral cavity such as alcohol, and safe solvents such as water that can be used for diluting the gelling agent.

Release liner These denture adhesive compositions may have a release liner. This release liner is a variety of materials that exhibit low affinity (including zero affinity) for the denture adhesive composition compared to the affinity that the denture adhesive composition exhibits for itself and the backing. Can be formed from In one embodiment, the release liner comprises polyethylene, paper, polyester, or other material and is subsequently coated with a non-stick material.

  Denture adhesive compositions also have many properties. In one embodiment, the composition is biodegradable, non-aqueous, or a combination thereof. In some embodiments, the composition of the present invention corrodes.

  The denture adhesive composition and its components may have any combination of the elements and properties disclosed herein.

Manufacturing method The denture adhesive composition can be manufactured by several methods. As an example of a manufacturing method, a) a viscosity index improver and / or water-insoluble component is added to the container, b) the viscosity index improver and / or water-insoluble component is heated and mixed to at least about 55 ° C., c) Adding and mixing a denture adhesive component. The order of addition of the above components is considered less important as long as the adhesive component is present in the composition when the viscosity index improver and / or water-insoluble component is present in a substantially liquid form. ing. The temperature of the process needs to be adjusted based on the requirements for the viscosity index improver and / or water-insoluble component used.

  The preformed compositions herein can be produced by conventional methods in the art, for example, in the film manufacturing industry such as casting, coating, calendering, and extrusion. In one embodiment, the individual components of the composition are melted and then mixed in a mixing tank until a uniform combination is obtained. Thereafter, the molten mixture may be cast onto a suitable substrate at an acceptable thickness. Examples of such substrates include Mylar, continuously running stainless steel belts (if necessary, eventually enter the dryer section), release paper, and the like. Subsequently, the composition is cooled. Next, if necessary, the composition may be dried, for example, in a blow dryer. The drying air temperature and drying time depend on the nature of the solvent utilized, as is recognized in the art. Generally, the drying temperature is from about 25 ° C. to 140 ° C., in another embodiment at a temperature between about 60 ° C. and 90 ° C., for about 20 minutes to about 60 minutes, in another embodiment about 30 to about 40 minutes. The duration can be mentioned. The composition may then be cut into the desired shape with the desired dimensions and then stacked and / or subsequently packaged.

  Another known film manufacturing method known in the art is extrusion. This method is possible when the film-forming component of the film contains various extrudable materials. The mechanical details of the extrusion process, such as the particular equipment used, extrusion force, orifice and / or die shape and temperature, are considered within the skill of the art and are described herein. Changes can be made in known manner to achieve the physical properties of the composition.

  In one embodiment, the thickness of the preformed composition herein is generally about 0.1 mm to about 2.5 mm, in another embodiment about 0.4 mm to about 1.5 mm thick, In embodiments, the thickness is from about 0.5 mm to about 1 mm. The composition may be thicker or thinner depending on the degree of buffering desired by the user.

Use of the composition The composition is generally applied to the denture and / or oral cavity, after which the denture is fixed to the oral cavity. In one embodiment, the denture is dried prior to application of the denture adhesive composition. In one embodiment, it is not necessary to wet the composition and / or denture before applying the composition to the denture and / or oral cavity in order for the composition to adhere to the denture and / or oral cavity. The composition may be applied to the denture and / or any suitable location on the oral cavity. In one embodiment, the denture wearer typically wears the composition for about 1 hour to about 3 days, in another embodiment about 6 hours to about 24 hours. After use, the denture can be removed from the oral cavity and any residual composition can be cleaned from the denture by gently rubbing it with, for example, water and a brush.

Test method Preparation procedure of reference sample (RS) and prototype sample (PS) The reference sample is regarded as a standard and is produced using the water-insoluble component of the standard product, whereas the prototype sample is The viscosity index improver to be evaluated is used.

Materials 1. Standard denture adhesive components and excipient powder (for both RS and PS sample preparation) i. Ca (47.5) / Zn (17.5) MVE / MA (methyl vinyl ether / maleic acid) mixed partial salt (33%)
ii. Sodium carboxymethylcellulose (20%)
iii. Colloidal silicon dioxide (1.14%)
2. Water-soluble components (WIC) and viscosity index improvers iv. RS sample preparation using standard WIC Mineral oil (Drakeol 35 from Penreco) (23.95%) + white petrolatum ("Snow" from Penreco) (21.91%)
Or Preparation of PS sample using prototype viscosity index improver and WIC Mineral oil (Drakeol 35 from Penreco) (40.812%) + prototype viscosity index improver (5.048%)

Procedure Prepare both the reference sample and the prototype sample by the following procedure.

  A mixer with a wall scraper blade (Haagen and Rinau Unimix) and a hot water jacket is connected to the water bath and vacuum pump. Set the water bath of the hot water jacket to about 95 ° C. Place the WIC and / or viscosity index improver components in a mixer vessel. If the water-insoluble components and / or viscosity index improvers are not liquid at room temperature, they are allowed to soften before switching on the agitator. The agitator is set at about 60 RPM and the WIC and / or viscosity index improver components are mixed until the temperature reaches about 95 ° C. "Standard denture adhesive ingredients and excipient powder" is added to the mixer via a funnel with the vent open. Close the vent and stop mixing. Scrub off the powder mass. Resume mixing at approximately 60 RPM. Vacuum to about 81.27 kPa (24 inches Hg) and mix until the batch reaches about 90 ° C. Reduce water bath temperature to about 60 ° C. and continue to mix under vacuum until batch is about 65 ° C. Stop mixing, stop pump, slowly open vent, release vacuum, open lid. Fill the sample into a suitable container such as a foil tube with a capacity of about 41.4 mL (1.4 oz). Allow the sample to equilibrate for about a week. Squeeze out the tube just before the evaluation and discard the first about 2 g.

  As far as possible, RS and PS are produced with the same denture adhesive component and excipient powder at the same concentration and in the same manufacturing procedure. This is done to provide a standard matrix for testing the differences between the various viscosity index improvers by keeping all variables including denture adhesive components and sample preparation procedures the same. Among other properties imparted by standard denture adhesive components, they also provide a standard driving force for saliva and moisture to penetrate through the denture adhesive composition.

  It is necessary to correspond to various characteristics of the trial viscosity index improver or the viscosity index improver / water-insoluble component mixture which does not correspond to the procedure detailed above (for example, when softening only at a temperature exceeding 95 ° C.) In some cases, the processing temperature profile can be changed as needed. Similarly, if the standard denture adhesive component described above is not appropriate, only a single denture adhesive component can be used, for example, 53% sodium carboxymethylcellulose instead of the combination with Ca / Zn MVE / MA salt. Furthermore, if the test formulation described above gives a PS that is high viscosity for instantaneous viscosity testing as described below, it may be necessary to dilute the sample with additional water-insoluble components such as mineral oil.

  The above process evaluates the viscosity index improver at a concentration of about 5%. Evaluation of the prototype viscosity index improver at 5% helps to set the reference value, ie finding the properties of the viscosity index improver at 5% concentration is an indicator of the properties of the viscosity index improver at high concentrations It is considered to be. That said, a prototype viscosity index improver that was evaluated at 5% and found to have no viscosity index improver properties at that concentration may have a higher concentration and is evaluated at a higher concentration for confirmation. Should.

  The above process can also be scaled up and used for general manufacturing at temperatures appropriate for the water-insoluble components of the viscosity index improver and / or denture adhesive composition.

Instantaneous Viscosity Ratio Test The instantaneous viscosity ratio can be measured and calculated by the following procedure.

Equipment ● Ares strain control rheometer ● 25mm permanent parallel plate

Method 1. Place a 25 mm parallel plate on the Ares rheometer.
2. Zero normal force.
3. Zero the gap at 25 ° C. (ie room temperature).
4). Samples are applied to the bottom plate in a semicircular motion across the parallel plates. When a gap of 2.177 ± 0.005 mm is reached, there should be enough sample to cut off the excess and spread the sample evenly on all edges so that there is no gap.
5. The gap is adjusted by the following procedure.
● Click the gap setting icon. The command gap position is set to 2.55 mm.
● Set the maximum allowable force to 100g.
● Click the gap setting.
● Cut off the sample with a plastic cover slide.
● Set the mand gap position to 2.177 mm and allowable maximum force = 100 g.
● Click the gap setting.
● Cut off the sample with a plastic cover slide.
● Set the command gap position to 2.147 mm and allowable maximum force = 100 g.
● Click the gap setting.
● Do not cut the sample.
● The final gap reading should be 2.147 ± 0.005 mm.
● Equilibrate the temperature to 25 ° C.
● Record the gap and axial force in the test notebook with each observation record.
● Start the experiment.
6). Start of test ● The method is a step rate (transient) test with the following procedure.
i. A rate of 0 / s is applied to 1s (1s delay).
ii. 5 / s is applied to 5s.
● Results are shown as a viscosity vs. time curve.
7). Record the peak viscosity value (aka “instantaneous viscosity”) of this curve.
8. Repeat steps 1-7 for PS at 25 ° C-at least 3 times 9. Repeat steps 1-7 for PS at 40 ° C-at least 3 times Average value of instantaneous viscosity of PS at 10.25 ° C, and 40 The value in ° C is calculated separately.
11. Finally, calculate:
● “Instant Viscosity Ratio” = (Average Instantaneous Viscosity of Composition at 40 ° C.) / (Average Instantaneous Viscosity of Composition at 25 ° C.)

  The following examples further describe and demonstrate embodiments within the scope of the present invention. These examples are presented for illustrative purposes only and should not be construed as limiting the invention. Many variations of these can be made without departing from the spirit and scope of the invention.

  The following are non-limiting example embodiments of the present invention.

Example I

(Example I (continued))

  In the above example, the above-mentioned “reference sample preparation procedure” is added with all non-powder-containing components not specifically listed in the procedure, and the water-insoluble component / viscosity index improver and all powdery components are added. It is produced by adding the ingredients together with the denture adhesive ingredient.

  All documents cited in “Mode for Carrying Out the Invention” are incorporated herein by reference in their relevant part, but any citation of any document admits that it is prior art with respect to the present invention. It should not be interpreted as a thing.

  While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims (5)

A denture adhesive composition comprising:
a) 10 % to 99 % by weight of the denture adhesive component of the denture adhesive composition, comprising AVE / MA, AVE / MA salt, AVE / MA mixed salt or a combination thereof, and sodium carboxymethylcellulose When,
have a moment viscosity ratio greater than b) 0.25, natural oils, synthetic oils, essential oils, and are selected from the group consisting of, 20% by weight of the denture adhesive composition to 70 wt% A water-insoluble component of
A denture adhesive composition comprising: Before Kiten natural oils comprises mineral oil, denture adhesive composition according to claim 1.   The denture adhesive composition of claim 1, wherein the composition can be dispensed from a tube.   The denture adhesive composition of claim 1, wherein the article is preformed.   The denture adhesive composition according to claim 4, further comprising a backing layer.